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OpenTrials
Completed

NCT Number: NCT00502827

Smoking Cessation for HIV/AIDS Patients

The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.

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Key information

About this study

If you agree to take part in this study, researchers will first do a test to learn what the CO level of your blood is. To do this test, you will be asked to blow into a cardboard tube. If the test finds that you are ineligible, you will not be able to continue on this study.

If you are found to be eligible, you will be enrolled in this study and asked to complete an interview that should last about 1 hour. During this interview, you will be asked basic questions, such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and stress. You will then be asked to complete a short test that involves completing some basic tasks, such as remembering several words and drawing a simple shape. This test, which will take about 2-5 minutes to complete, is used to measure attention and concentration.

You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being assigned to either group.

If you are assigned to Group 1, you will receive advice from your physician/provider to stop smoking and written materials designed to help you quit smoking.

If you are assigned to Group 2, you will receive the advice from your physician/provider to quit smoking and the written materials, but you also be given a cell phone and be called 11 times over the course of an 12 to 13 week period. During these calls, which will last about 10 minutes, you will be asked to talk about smoking and quitting smoking. Access to a hotline number that you can call to speak with a counselor about quitting smoking will also be given to you if you are assigned to group 2. Participants in Group 1 will not get the number to the hotline. There is a limited number of prepaid minutes on the phone, so participants who receive a cell phone should make an effort to save enough minutes to complete this study.

You will be asked to complete three more interviews about 3-, 6-, and 12-months after the first interview. During these interviews, you will again be asked questions about your smoking behavior, mood, quality of life, and stress. All three of these interviews will take about one hour to complete. Your participation in this study will be complete after the 12-month interview.

Lost, stolen, or broken cell phones will not be replaced, but participants will remain on study.

This is an investigational study. Up to 705 participants will take part in this research study. All participants will be enrolled at Thomas Street Clinic.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-positive
  • 18 years of age or older
  • Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
  • English or Spanish speaking
  • Able to provide written informed consent to participate
  • Willing to set a quit date within 1 week of baseline assessment

Exclusion criteria

  • Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
  • Current participation in another smoking cessation program

Treatment and study plan

Cell Phone Intervention

Behavioral

Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking.

Other names: CPI

Recommended Standard of Care

Other

Advice from your physician to stop smoking and written materials designed to help you quit smoking.

Other names: RSOC

Primary outcomes

  1. Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence

    Time frame: 1 year after quit date

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

An Innovative Telephone Intervention for HIV-Positive Smokers

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2007
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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